study of pneumrx endobronchial coil system in treatment of subjects with severe emphysema

Conditions: Emphysema

Summary: this study will look at outcomes between endobronchial coil treatment and control groups in patients with severe heterogeneous and or homogeneous emphysema.

this will be a prospective, multicenter, randomized, controlled study comparing outcomes between the endobronchial coil and control groups. subjects will be block randomized in a treatment to control ratio of 2:1. the randomization will be stratified by site and homogeneous versus heterogeneous emphysema, to support a balance of patients with differing heterogeneity in both the treatment and control groups

Eligibility criteria:
inclusion criteria: * read, understood and signed the informed consent form * meets indications for use per the ifu * bilateral heterogeneous and/or homogeneous emphysema * post bronchodilator 15% predicted ≤ forced expiratory volume in 1 second (fev1) ≤ 45% predicted * post bronchodilator residual volume (rv) ≥ 200% predicted * post bronchodilator total lung capacity (tlc) \>100% pred. * post bronchodilator rv/tlc \> 55% * dyspnea related to hyperinflation scored ≥ 2 on modified medical research council (mmrc) dyspnea scale despite optimal medical management * receiving optimal drug therapy and medical management according to clinical practice. * performing regular physical activity, at least 2 times per week * stopped smoking as confirmed by carboxyhemoglobin (cohb) * 100m ≤ 6 minute walk distance (6mwd) ≤ 450m * deemed eligible per eligibility review committee (erc) * if treated in france, subject must be entitled to french social security. exclusion criteria: * known sensitivity to drugs required for performing bronchoscopy or in whom bronchoscopic procedures are contraindicated * evidence of active infection in the lungs * hypersensitivity or allergy to nitinol (nickel-titanium) or its constituent metals * clinical significant pulmonary fibrosis * clinically significant, generalized bronchiectasis * clinically significant bleeding disorders * patient taking immunosuppressive drugs other than steroids (e.g., for the treatment of cancer, rheumatoid arthritis, autoimmune disease, or prevention of tissue or organ rejection). * primary diagnosis of asthma * two (2) or more copd exacerbations in the prior year, or 1 or more copd exacerbations in the prior 3 months with indication for hospitalization assessment, according to gold 2017 recommendations . * predominant small airways disease defined as significant bronchiectasis with sputum production (\> 2 tablespoons daily) or significant bronchial wall thickening per high resolution computed tomography (hrct) * percent low attenuation area (%laa) \< 20% in the most damaged lobe of either lung. * computed tomography (ct) imaging consistent with active pulmonary infection, significant interstitial disease or pleural disease * severe bullous disease (defined by bulla \> 8cm or 1/3 of lung volume, or single bullous defect \>8 cm) or predominant paraseptal emphysema \[defined by numerous large (\>1cm) paraseptal defects in the target lobe comprising of \>5% of total lung volume\]. * lung pathology of nodule not proven stable or benign * radiographic confirmation of atelectasis or other scarring/fibrosis in areas of intended coil implant * use of more than 20 mg/day prednisolone or equivalent dosage of a different corticosteroid * severe pulmonary hypertension (right ventricular systolic pressure (rvsp) \> 50 mm hg or other signs of pulmonary hypertension (pht) with right ventricular dysfunction) * severe hypercapnia (paco2 \> 55 mmhg on room air) and/or severe hypoxemia (pao2 \< 45mm hg on room air, high altitude criterion: pao2 \< 30 mm hg) * previous lung volume reduction (lvr) surgery, lung transplantation, lobectomy, lvr devices or other device to treat copd in either lung. * diagnosed with alpha-1 antitrypsin deficiency * diffusion capacity of the lungs for carbon monoxide (dlco) \< 20 % * significant, recent or unstable cardiac disease defined as severe heart failure (left ventricular ejection fraction (lvef) \< 45% despite optimal medical management), unstable cardiac arrhythmia or coronary artery disease (angina on activity), or ischemic event in the past 6 months. * body mass index (bmi) \> 30 * participation in any other clinical study. * subject is pregnant or lactating, or plan to become pregnant within the study timeframe. * if treated in france, subject is a "personnel vulnerable" as defined by french regulation

Keywords: severe heterogeneous emphysema severe homogeneous emphysema